inforMED
MalfunctionIXY

GENESYS

Received Aug 27, 1999 · Event occurred Nov 23, 1998

Report 2916556-1999-00139 · MDR key 237817

Device

Generic name

Nuclear Medicine Equipment

Manufacturer

Adac Laboratories

Model number

2129-3011A

Catalog number

NA

Lot number

NA

Product problems

  • Device Alarm System
  • Unintended Collision
  • Failure to Sense
  • Sensor problems
  • Other (for use when an appropriate device code cannot be identified)

Patient

*

  • Therapy/non-surgical treatment, aborted/stopped
  • Therapy/non-surgical treatment, additional

Narrative

Description of Event or Problem

WHEN DOING A PREPROGRAMMED BONE SCAN ON A PT, THE DETECTOR CONTACTED THE PT'S HEAD BUT THE COLLIMATOR COLLISION SENSING DEVICE DID NOT ACTIVATE. THE TECH HAD TO STOP THE PROCEDURE MANUALLY. THE PT DECLINED ANY MEDICAL EXAMINATION AND LEFT. THE FOLLOWING DAY HE RETURNED AND REC'D AN X-RAY AND CT.

Remedial action

  • Other